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Transcript

Food Additives
Legislation Guidance
to Compliance
October 2015
For all queries about this guide to compliance — including if you
require the information in an alternative format such as audio, large
print or Braille — please use the number below.
CONTACT TELEPHONE
0207 276 8570
Summary
•
•
•
Intended audience:
Manufacturers and processors
Retailers and caterers.
Enforcement officers
Which UK nations
does this cover?
England, Scotland, Wales and Northern Ireland
Purpose:
The guide to compliance aims to provide information about
the requirements of revised EU food additives legislation,
which applied from 1 June 2013.
Legal status:
Regulatory guide to compliance (Information specifying
what food business operators need to do to comply with EU
legislation)
•
Key words
Additives
Review date
October 2016
Sunset date
October 2018
Revision history
This guidance follows the Government Code of Practice on Guidance. If you believe this
guidance breaches the Code for any reason, please let us know by emailing
[email protected] If you have any comments on the guidance itself,
please call us using the contact number on page 2 or complete our ongoing Guidance
survey: https://www.surveymonkey.com/s/55QQDCG
Revision
No.
Revision date
Purpose of revision and
paragraph number
Revised by
To take account of
1
July 2014
Food additives – Regulation 1333/2008
amendments to EU
legislation on additives in
Glynis Griffiths
meat preparations
(Commission Regulation
(EC) 601/2014) (paragraphs
2
October 2015
57-61)
To update details of Scottish
contact (paragraph 3)
2
October 2015
Food additives – Regulation 1333/2008
To update information on
general labelling legislation
(paragraph 31)
3
Glynis Griffiths
October 2015
Contents
SUMMARY ........................................................................................................................ 2
PURPOSE AND LEGAL STATUS OF GUIDANCE ........................................................... 7
REVIEW ............................................................................................................................ 7
CONTACTS ....................................................................................................................... 7
INTRODUCTION ............................................................................................................... 7
REGULATION 1333/2008 ................................................................................................. 9
GENERAL REQUIREMENTS OF THE LEGISLATION .................................................... 9
SUBSTANCES EXCLUDED FROM THE SCOPE OF ADDITIVES LEGISLATION
(ARTICLE 3) ......................................................................................................... 10
EU LISTS OF FOODS ADDITIVES (ARTICLES 4, 7 AND 8) ........................................... 11
CONDITIONS OF USE FOR ADDITIVES IN FOODS, INCLUDING MAXIMUM
LIMITS, PROHIBITION OF ADDITIVES IN UNPROCESSED FOODS ETC.
(ARTICLES 4, 5, 11, 15 AND 16) ......................................................................... 12
GM ADDITIVES, ADDITIVES PRODUCED FROM NEW SOURCES OR DIFFERENT
PROCESSES (E.G. NANO TECHNOLOGY) (ARTICLES 12 AND 13) ................ 12
CARRY-OVER RULE (ARTICLE 18) ................................................................................ 13
RULES ON THE LABELLING OF FOOD ADDITIVES SOLD AS SUCH TO OTHER
BUSINESSES AND TO CONSUMERS (ARTICLES 21- 23) ................................ 14
SPECIFIC LABELLING REQUIREMENTS FOR SIX AUTHORISED FOOD
COLOURS (ARTICLE 18) .................................................................................... 15
“COLOURING” FOODS ................................................................................................... 16
ANNEX II OF COMMISSION REGULATION 1333/2008 .................................................. 16
STRUCTURE OF ANNEX II .............................................................................................. 17
Food additives – Regulation 1333/2008
4
October 2015
ANNEX III TO REGULATION 1333/2008 .......................................................................... 18
DATES OF APPLICATION ................................................................................................ 18
STRUCTURE OF ANNEX III ............................................................................................. 18
SPECIFICATIONS ............................................................................................................. 20
AMENDMENTS TO ANNEXES II AND III ......................................................................... 20
APPROVAL FOR NEW ADDITIVES, NEW USES OF ALREADY AUTHORISED
ADDITIVES ........................................................................................................... 21
GUIDANCE ON SCIENTIFIC REQUIREMENTS AND DATA SUBMISSION .................... 22
EUROPEAN FOOD SAFETY AUTHORITY RE-EVALUATION OF FOOD
ADDITIVES ........................................................................................................... 22
APPENDIX 1 ..................................................................................................................... 22
DIFFERENCES BETWEEN ANNEX II AND EC COMMISSION DIRECTIVES
95/2/EC, 94/35/EC AND 94/36/EC ....................................................................... 22
MEAT PREPARATIONS .................................................................................................... 24
FOOD CATEGORY DESCRIPTORS................................................................................. 25
APPENDIX 2 ..................................................................................................................... 25
TRANSITIONAL PROVISIONS ......................................................................................... 25
ANNEX II OF REGULATION 1333/2008 ........................................................................... 25
ANNEX III OF REGULATION 1333/2008 .......................................................................... 25
COMMISSION REGULATION (EU) NO. 380/2012 ........................................................... 26
APPENDIX 3 ..................................................................................................................... 26
NITRITES AND NITRATES IN MEAT PRODUCTS........................................................... 26
TRADITIONAL MEAT PRODUCTS .................................................................................. 28
TRADITIONAL PRODUCTS WHICH DO NOT FIT INTO ANY NAMED CATEGORY ...... 28
Food additives – Regulation 1333/2008
5
October 2015
“SIMILAR PRODUCTS” ................................................................................................... 29
DRY CURED HAM ............................................................................................................ 29
WILTSHIRE BACON/HAM ................................................................................................ 29
CURE-IN-THE-BAG PRODUCTS ..................................................................................... 30
NON-HEAT-TREATED MEAT PRODUCTS ...................................................................... 30
‘BACON, FILET DE BACON’ ........................................................................................... 31
CONVERSION FACTOR FOR POTASSIUM SALTS ........................................................ 31
VEGETABLE EXTRACT NITRITES .................................................................................. 31
APPENDIX 4 ..................................................................................................................... 31
MAXIMUM USABLE DOSES FOR SALT OF ASPARTAME-ACESULFAME .................. 31
METHOD OF CALCULATING PERMITTED LEVELS OF SALT OF ASPARTAME–
ACESULFAME ..................................................................................................... 32
Food additives – Regulation 1333/2008
6
October 2015
Purpose and legal status of guidance
1.
This updated guide to compliance has been produced to provide advice on the legal
requirements of Council Regulation (EC) No. 1333/2008 (“Regulation 1333/2008”) on
food additives. It cannot cover every situation and you may need to consider the
relevant legislation itself to see how it applies in your circumstances. If you do follow
the guide to compliance, it will help you to comply with the law. Businesses with
specific queries may wish to seek the advice of their local enforcement agency, which
will usually be the trading standards/environmental health department of the local
authority/district council.
Review
2.
It is planned to review this guide to compliance in October 2016. We welcome
feedback from users of the guidance, including completion and return of the feedback
questionnaire
Contacts
3.
For help and advice on this guidance in England please contact the food additives
helpline on 0207 276 8570 or [email protected] .
For Wales contact: 029 2067 8912 Email: [email protected]
For Northern Ireland contact: [email protected]
For Scotland, responsibility falls to Food Standards Scotland (FSS): contact
[email protected]
Introduction
4.
A European Union legislative package on “food improvement agents” was published
at the end of 2008. This replaced earlier EU legislation and comprised three
individual Regulations on food additives, flavourings and enzymes and a Regulation
providing a common authorisation procedure for all three. The core principles and
provisions of food additives legislation are set out in European Parliament and
Council Regulation (EC) No. 1333/2008, which is available at the following website:
Food additives – Regulation 1333/2008
7
October 2015
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:354:0016:0033:EN:PDF
Food additives – Regulation 1333/2008
8
October 2015
Regulation 1333/2008
5.
Regulation (EC) No 1333/2008 is enforced in England by the Food Additives,
Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013 (SI 2013
No. 2210 available from: www.legislation.gov.uk website.
6.
Parallel measures exist in Scotland, Wales and Northern Ireland.
 The Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales)
Regulations 2013 (WSI 2013 No. 1591 (W255))
 The Food Additives, Flavourings, Enzymes and Extraction Solvents Regulations
(Northern Ireland) 2013 (SR 2013 No.220)
 The Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland)
Regulations 2013 (SSI 2013 No. 266)
General requirements of the legislation
7.
The Regulation provides for :
a) Community 1 lists of approved food additives which are set out in Annex II and III of
the Regulation;
b) Conditions of use for food additives used in foods, including in food additives, food
enzymes as covered by Regulation (EC) No. 1332/2008, food flavourings as covered
by Regulation (EC) No.1334/2008 and nutrients;
c) rules on the labelling on food additives sold as such;
d) specific rules on the “carry-over” principle;
e) rules on the labelling of the so called “Southampton colours”.
f) specifications (purity criteria) to be established for permitted food additives.
1
Following the Treaty of Lisbon, the European Community became the European Union, and references to
“Community” in pre-Lisbon legislation are to be read as references to the EU.
Food additives – Regulation 1333/2008
9
October 2015
Substances excluded from the scope of additives legislation
(Article 3)
8.
The legislation includes a definition of food additive at Article 3.2 (a),
• “any substance not normally consumed as a food in itself and not normally used as a
characteristic ingredient of food, whether or not it has nutritive value, the intentional
addition of which to food for a technological purpose in the manufacture,
processing, preparation, treatment, packaging, transport or storage of such food
results, or may be reasonably expected to result, in it or its by-products becoming
directly or indirectly a component of such foods”.
9.
Any substance, whatever its function, that does not meet this definition, is not
controlled by Regulation 1333/2008. Thus, in particular, the Regulation does not
apply to normal food/food ingredients, even if they are added to perform a controlled
function. The definition includes, for clarification purposes, a list of substances that
for the purpose of the Regulation are not considered as food additives. There are a
number of substances, such as calcium carbonate or sodium ascorbate, which are
used both as food additives and in food supplements or fortified foods. The primary
purpose for which these are used will determine the legislation that will apply.
10. Processing aids, including filtration aids and release agents, defined at Article 3.2 (b),
are also excluded from the scope of Commission Regulation 1333/2008. In the UK,
there is no national legislation on processing aids nor is there any legally defined list
of approved processing aids either within the UK or within EU. “Processing aid”,
means any substance which:
I.
is not consumed as a food by itself;
II.
is intentionally used in the processing of raw materials, foods or their ingredients, to
fulfil a certain technological purpose during treatment or processing; and
III.
may result in the unintentional but technically unavoidable presence in the final
product of residues of the substance or its derivatives provided they do not present
any health risks and do not have any technological effect on the final product.
11. Other substances falling outside the scope of the Regulation include extraction
solvents falling within the scope of EC Directive 2009/32/EC, flavourings falling within
the scope of Regulation (EC) No. 1334/2008, and food enzymes falling within the
scope of Regulation 1333/2008. Food additives legislation will however continue to
Food additives – Regulation 1333/2008
10
October 2015
regulate the use of food additive enzymes (e.g. invertase and lyzosyme) until such
time as the positive list of food enzymes is established. Also excluded are substances
added to foods as nutrients e.g. minerals, trace elements or vitamins, substances
used for the protection of plants and plant products in conformity with European
Union rules on plant health e.g. pesticides, herbicides and substances used for the
treatment of water. The use of additives in wine must comply with Regulation
1333/2008 and with the provisions in the relevant EU legislation on oenological
practices and processes.
12. Whether or not governed by specific regulations, the addition of any substance to
food is subject to the provisions of Regulation (EC) No. 178/2002 (General Food
Law) which prohibits the placing on the market of food that is unsafe, i.e. injurious to
health, or unfit for human consumption.
EU lists of foods additives (Articles 4, 7 and 8)
13. Lists of permitted food additives (including colours and sweeteners and
miscellaneous additives such as preservatives and antioxidants) can be found in
Annexes II and III of Regulation 1333/2008. Annexes II and III have been populated
by way of separate Regulations (Commission Regulations (EU) No’s 1129/2011 and
1130/2011) ‘as amended’.
14. To be included in the approved list, additives must comply with the conditions set out
in Regulation 1333/2008, which state that they should not present safety concerns,
should be technologically justified, and should not mislead the consumer. Additives
should also have advantages and benefits for the consumer such as preserving the
nutritional quality of food, enhancing its keeping quality or stability, aiding the
manufacture and processing of the product or in its transport or storage. Additional
specific conditions are also laid down for colours and sweeteners.
15. The functional classes of food additives are defined in Annex I. Some additives have
multiple technological functions. For example, Sodium Hydrogen Carbonate, which is
also known as Bicarbonate of Soda, or E 500, is best known as a raising agent but
can also function as an anti-caking agent or acidity regulator.
Food additives – Regulation 1333/2008
11
October 2015
Conditions of use for additives in foods, including maximum
limits, prohibition of additives in unprocessed foods etc.
(Articles 4, 5, 11, 15 and 16)
16. Regulation 1333/2008 prohibits the placing on the market of a food additive or any
food containing food additives if the use of the additive does not comply with the
requirements in the Regulation. This includes additives, which are used for a
technological function not listed in Annex I. In this case, an appropriate new function
will be assigned to the additive and added to the list in Annex I when the additive is
undergoing the authorisation process.
17. Conditions of use for food additives in foods, including restricted uses in specified
foods and maximum limits, are set out in Annex II.
18. The maximum limits in the annexes are based on the food as sold unless otherwise
specified. However, for dried and/or concentrated foods (including drinks), the
maximum limits apply to the food as reconstituted following manufacturers’
instructions, taking into account the minimum dilution factor. It is recognised that
certain substances, for example phosphates and glutamates, are naturally present in
certain foods. The quantitative limits apply to the amount of additive added. There is
however, an exception in the case of sulphites, as the legislation requires that the
specified quantitative limits include sulphites available from all sources and therefore
take into account any natural occurrence of the substance.
19. There are instances in the legislation where no numerical limit is set for additive use.
This is because there is no need on safety grounds to set a maximum level. Rather a
level of quantum satis (QS) is set. QS is defined in the legislation and means that
additives shall be used in the food concerned in accordance with good manufacturing
practice. This means that it must not be used at a level higher than is necessary to
achieve the intended purpose and must not be used in a way that misleads the
consumer.
GM additives, additives produced from new sources or
different processes (e.g. nano technology) (Articles 12 and 13)
20. A food additive falling within the scope of Commission Regulation (EC) No.
1829/2003 on genetically modified food will need to be covered by an authorisation
under that Regulation before it can be added to the list of permitted additives; e.g. an
Food additives – Regulation 1333/2008
12
October 2015
emulsifier made from GM soya oil would be permitted provided that the GM soya is
permitted under Commission Regulation (EC) No. 1829/2003 and the emulsifier
complies with the relevant EU specification.
21. If there is a significant change to the production methods or starting materials,
including particle size through nanotechnology, of an approved additive, it will be
considered a different additive and will need to undergo re-evaluation. Decisions as
to what constitutes a “significant change” are made on a case-by-case basis.
Carry-over rule (Article 18)
22.
“Carry-over” provisions apply to most foods permitted to contain food additives, but
not to those specially prepared for infants and young children. These provisions
permit the presence of a permitted food additive in a compound food, to the extent
that the food additive is allowed by the provisions of Annex II of Regulation
1333/2008 in one of the ingredients of the compound food (Article 18.1 (a) refers).
23.
Recital 16 of Regulation 1333/2008 should be taken into account when considering
applying the carry-over rule – this states that the level of the additive in the final food
should be no greater than would be introduced by the use of the ingredient under
proper technological conditions and good manufacturing practice, thus preventing
misuse of carry-over. Examples of carry-over are given below:
a) A fruit yoghurt consisting of plain (unflavoured) yoghurt and a fruit preparation
would be permitted to contain sorbates, are permitted in fruit preparations,
even though they are not permitted in plain yoghurts. The level used must
not exceed the maximum level for the fruit preparation element of the
yoghurt.
b) If a non-heat treated meat product is used as an ingredient in a compound
food (e.g. the cooked bacon in a bacon lettuce and tomato (BLT) sandwich),
the presence of nitrate would be permitted in the BLT sandwich up to the limit
permitted for the cooked bacon.
24.
The carry-over rule also provides for permitted food additives to be present in foods
(such as intermediary products) in which they would not otherwise be permitted,
provided that those foods are to be used solely in the preparation of a compound
food that will conform to the provisions of Annex II. The latter is commonly referred
Food additives – Regulation 1333/2008
13
October 2015
to as “reverse carry-over” (Article 18 (c) refers). Examples of reverse carry-over
are:
a) Annatto (not normally permitted to be used in seasonings) could be added to
a seasoning that is intended solely for use in a snack food, provided the level
of annatto does not result in the maximum level of annatto permitted for the
snack food being exceeded. The annatto would not be permitted to be
added to a seasoning that was intended to be used in a food that is not
permitted to contain annatto, such as a minced meat preparation.
b) Sodium bicarbonate (E 500, a Group 1 additive not normally permitted to be
used in self raising flour) could be added to self raising flour that is intended
solely for use in bread or fine bakery wares, as Group 1 additives are
permitted to be used in these foods.
25.
In addition, an additive may be present in a food to which a food additive, food
enzyme, food flavouring or nutrient has been added, provided that the additives is
permitted in accordance with the provisions of Annex III of Regulation 1333/2008
(see paragraphs 38-41 below), and has no technological function in the final food
(Article 18.1(b) refers). When it has a technological function in the final food it must
comply with the relevant provisions of use for that food (Article 18.3) refers.
26.
Certain foods (listed in tables 1 and 2 of Annex II of Regulation 1333/2008 are not
permitted to contain additives by way of carry-over. This includes unprocessed
foods. However, if an unprocessed food e.g. a fresh fish fillet, is coated with a
batter, the fish and the batter would be considered separate ingredients falling within
different food categories. The batter would be permitted to contain all Group 1
additives, even though most Group 1 additives are not permitted in fresh fish.
Rules on the labelling of food additives sold as such to other
businesses and to consumers (Articles 21- 23)
27.
Labelling requirements for business-to-business sales of food additives are set out
in Articles 21 – 22. By way of derogation from these rules, certain specified aspects
of the required information may be shown on the documents relating to the
consignment supplied with or prior to delivery rather than on label, if it is made clear
Food additives – Regulation 1333/2008
14
October 2015
that the product is not for retail sale. In addition, the required information on food
additives supplied in tankers may be shown on the accompanying document.
28.
Labelling requirements for sales of additives sold to consumers are set out in Article
23, which apply without prejudice to labelling rules for food in general. There are a
number of additional labelling requirements for table top sweeteners requiring that
the sweetener(s) present is indicated in the sales description (e.g. x based table
sweetener). Table top sweeteners containing polyols must carry the warning
“excessive consumption may induce laxative effects”, and table top sweeteners
containing aspartame or aspartame-acesulfame salt must be marked with the
indication “contains a source of phenylalanine”.
Specific labelling requirements for six authorised food colours
(Article 18)
29.
Foods containing Tartrazine (E 102), Ponceau 4 R (E 124), Sunset yellow (E 110),
Carmoisine (E 122), Quinoline yellow (E 104) and Allura Red (E 129) are required to
be labelled with the following additional information;
•
30.
‘name or E number of the colour(s)’: may have an adverse effect on activity and
attention in children’.
For those businesses who retained these colours and have to label their products
with the required warning notice, the FSA has produced guidance to assist them
with this. This is published on the FSA’s website at:
http://www.food.gov.uk/multimedia/pdfs/labellingcoloursreg13332008.pdf
31.
The use of food additives in food is covered by the general labelling rules as set out
in the Food Information to Consumers Regulation (EU) No. 1169/2011. The Food
Information Regulations 2014 establish enforcement measures for England; parallel
measures also exist for Scotland, Wales and Northern Ireland.
32. Guidance has also been drawn up which aims to assist businesses who want to
remove these colours and replace them with alternatives. This is aimed specifically at
assisting small and medium sized businesses.
Food additives – Regulation 1333/2008
15
October 2015
“Colouring” foods
33. EU guidance has been drawn up to distinguish between food colours, which are
subject to EU food additives legislation and colouring food extracts, which are not.
The guidance describes the criteria that determine the difference between selective
and non-selective extraction for the classification of food extracts/concentrates as
food colours or colouring foods and proposes a decision tree and checklist to
facilitate this classification. The guidance is aimed at industry and enforcement
authorities/regulators and is available on the European Commission’s website at:
http://ec.europa.eu/food/food/fAEF/additives/docs/guidance_en.pdf
Annex II of Commission Regulation 1333/2008
34. Following the adoption of Regulation 1333/2008, the European Commission was
tasked with transferring the existing food additives authorisations in the food additives
legislation being phased out (EC Directives 95/2/EC, 94/35/EC and 94/36/EC) and
populating Annex II of Commission Regulation 1333/2008. Following extensive
consultation with Member States and stakeholders, a Food Categorisation System
(FCS) was developed similar to that in the Codex General Standard for Food
Additives, but adapted to the EU market and to EU principles. An example of a food
category and its sub-categories in Annex II is set out below:
a)
Category 05 – confectionery
b)
Sub-category 05.1 – cocoa and chocolate products as covered by Directive
2000/36/EC
c)
Sub-category 05.2 – other confectionery including breath freshening micro sweets
d)
Sub-category 05.3 – chewing gum
35. All additives (colours, sweeteners and miscellaneous additives) permitted in each
sub-category of food are listed, together with conditions of use. In general, additives
not listed are not permitted to be used. However, category 0 covers food additives
(i.e. gases) which are permitted in all categories of food, and additives such as
silicates that are permitted in all dried powdered foods and category 18 covers
processed foods not covered by categories 1 – 17.
Food additives – Regulation 1333/2008
16
October 2015
36. Annex II was published as Commission Regulation (EU) No. 1129/2011 entered into
force on 2 December 2011 and applied from 1 June 2013. However, transitional
provisions were included to permit products complying with the previous Directives
on colours, sweeteners and miscellaneous additives to continue to be marketed up to
31 May 2013, details of which can be found in Appendix 2 below.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:295:0001:0177:En:PDF
Structure of Annex II
Part A – this includes:
• An introduction to the Annex and general provisions on listed additives and
conditions of use;
• Lists of colours that may not be sold directly to the consumer
• The requirement for nitrites to be sold in a mixture of salt or salt substitute,
• Lists of foods which are not permitted to contain additives or colours by way of the
carry-over principle.
Part B – this includes lists of all authorised additives (colours, sweeteners and additives
other than colours and sweeteners). The use of these additives in foods must comply with
the provisions in Part E of Annex II.
Part C – For ease of reference, certain additives are grouped together in Part E of Annex II
and the groupings are defined in Part C. Group I comprises generally permitted additives,
Group II comprises food colours authorised at quantum satis level, Group III covers food
colours with a combined maximum limit and Group IV covers polyols. In addition, other
additives that have a common reporting basis e.g. sorbates or sulphites are grouped
together.
Part D – a list of all the food categories and sub-categories within the FCS are set out in
Part D. There are 18 food categories, including category 0, which covers food additives
(i.e. gases) that are permitted in all categories of food, and additives such as silicates,
which are permitted in all dried powdered foods. Category 18 covers processed foods not
covered by categories 1-17. As additives can only be used in the food categories listed, it
was decided to include a category that would cover any foods that may have been
overlooked when the FCS was created.
Food additives – Regulation 1333/2008
17
October 2015
Part E - comprises food categories and authorised additives. The additives (where
appropriate grouped together) are listed against the 153 sub-categories by E number and
name with conditions of use (including the maximum limit) indicated. Also indicated are
any restrictions or exceptions on the additive use in that sub-category and footnotes are
included where appropriate. Some additives are approved for use across the broader food
category whereas others are permitted in specific food products only e.g. Group 1
additives are permitted in all foods in category 8.2.1 (non-heat-treated-processed meat)
whereas E 100 curcumin is permitted only in sausages and pasturmas.
Annex III to Regulation 1333/2008
37. Annex III to Regulation 1333/2008, the content of which was amended and
substantially populated by Commission Regulation (EU) No. 1130/2011, lists the
additives that are permitted for use in additives, including carriers, in food enzymes,
in food flavourings and in nutrients.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:295:0178:0204:EN:PDF
Dates of application
38. Commission Regulation 1130/2011 entered into force and became applicable on 2
December 2011. However, transitional provisions have been included to permit
products complying with preceding legislation to be marketed up to specified
deadlines, details of which can found in Appendix 2.
Structure of Annex III
Part 1 - covers carriers used in other additives. Carriers are defined in Regulation
1333/2008 as substances, which are used to:
“Dissolve, dilute, disperse or otherwise physically modify a food additive or a
flavouring, food enzyme, nutrient and/or other substance added for nutritional or
physiological purposes to a food without altering its function (and without exerting
any technological effect themselves) in order to facilitate its handling, application or
use”
39. Some of the carriers listed in Part 1 can be used in all additives, and others are
restricted to certain categories of additives only, e.g. anti-foaming agents, sweeteners
Food additives – Regulation 1333/2008
18
October 2015
and glazing agents for fruit. Most are permitted at quantum satis level. The maximum
limit is based on the additive preparation itself, except in the case of E 1520 where
the limit relates to the carry-over level in the final food.
Part 2 - covers additives (except carriers) used in other additives. Additives listed in Table
1 of Part 6 can be used in all additive preparations at quantum satis level; the other listed
additives are restricted to certain categories of additives only. Maximum permitted levels
are based on the additive preparation in the case of phosphates and silicates; in all other
cases, limits are set for the food additive preparation and for the final food.
Part 3 - covers additives (including carriers) used in food enzymes. Additives listed in
Table 1 of Part 6 of the Regulation can be used in food enzyme preparations at quantum
satis level. Maximum permitted levels are based on the enzyme preparation in the case of
phosphates and silicates; in all other cases, limits are set for the enzyme preparation and
for the final food. Only specified ones can be used as carriers.
Part 4 - covers additives (including carriers) used in food flavourings. Additives listed in
Table 1 of Part 6 of the Regulation can be used in flavourings at quantum satis level.
Maximum permitted levels are based on the flavouring preparation in most cases, but in
specified cases, limits are set for the flavouring preparation and for the final food.
Part 5 (Section A) - covers additives (including carriers) used in nutrients, except those
added to nutrients to be used in foods for infants and young children.
Part 5 (Section B) - covers additives added to nutrients to be used in foods for infants and
young children listed in Category 13.1 of Part E of Annex II.
Part 6 (tables 1– 7) - sets out the various groupings of food additives.
Food additives – Regulation 1333/2008
19
October 2015
Specifications
40. Food additives must comply with the approved specifications set out in EC
Regulation (EU) No. 231/2012 . The specifications comprise information, which
adequately identifies the food additive, including origin and description of the
manufacturing process, and establish acceptable purity criteria for each additive,
such as maximum limits for undesirable impurities.
http://eurlex.europa.eu/JOIndex.do?year=2012&serie=L&textfield2=83&Submit=Search&_submit=Sea
rch&ihmlang=en
41. EC Regulation (EU) No. 231/2012 laying down specifications for food additives listed
in Annexes II and III of Regulation 1333/2008 was adopted on 9 March 2012. The
new Regulation, which consolidates and repeals the three previous purity criteria
Directives, includes a number of technical changes and clarifications whilst
specifications for additives, which are no longer permitted, have been removed (e.g.
Red 2G). It applied from 1 December 2012.
Amendments to Annexes II and III
42. A number of Regulations amending Annexes II and III to Regulation 1333/2008 have
already been published. Some of these restrict the permitted uses of authorised
additives whilst others permit the use of newly approved additives or new uses of
existing additives. In particular, EC Regulation (EU) No. 1131/2011, which came into
force on 2 December 2011, permits steviol glycosides to be used in certain specified
foods at maximum specified levels.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:295:0205:0211:EN:PDF
43. EC Regulation (EU) No. 380/2012, which came into force on 23 May 2012, amends
Annex ll to restrict the use and levels for aluminium-containing food additives. The
measures restrict the use of aluminium silicates (commonly used as anti-caking
agents), aluminium lakes (a base for certain food colours), and limit the raising agent
E541 Sodium Aluminium Phosphate (SALP) to one product only, Battenburg-style
cakes. Transitional arrangements have been agreed to allow industry to adapt to the
proposed changes. Details of these are set out in Appendix II below.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:119:0014:0038:EN:PDF
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44. EC Regulation (EU) No. 232/2012, which came into force on 23 May 2012, amends
Annex ll to restrict the use and levels for three colours – E 104 Quinoline Yellow, E
110 Sunset Yellow and E 124 Ponceau 4R. The levels of these colours are now
restricted in a number of food categories, including soft drinks, confectionery, sauces
and seasonings and in some cases (for example Ponceau 4R in sauces and
seasonings) no longer permitted. The Regulation includes a use level of 20 mg/l for
Sunset Yellow in soft drinks. EC Regulation 232/2012 is directly applicable in
Member States’ legislation and applied from 1 June 2013. Foods placed on the
market that comply with the provisions of the previous legislation (EC Directive
94/36/EC) can continue to be marketed until stocks are exhausted.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:078:0001:0012:en:PDF
45. The European Commission’s food additives database includes links to all the food
additives legislation and can also be used to access the additives and approved
conditions Whilst not a legal document it is a useful reference source as it updated
by the European Commission to reflect the changes to the Annexes in Regulation
1333/2008.
https://webgate.ec.europa.eu/sanco_foods/main/?event=display
Approval for new additives, new uses of already authorised
additives
46. Commission Regulation (EU) No 234/2011 sets out the authorisation procedure for
food additives as well as for food enzymes and food flavourings:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:064:0015:0024:EN:PDF
47. All applications for new additives and new uses of permitted additives should be sent
to the European Commission. Guidance regarding the submission of an application
and the procedures involved in such an application are available on the
Commission’s website, via the link below:
http://ec.europa.eu/food/food/fAEF/authorisation_application_en.htm
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Guidance on scientific requirements and data submission
48. EFSA have produced guidance on submissions for food additives, detailing specific
scientific approaches and data requirements for food additives evaluations:
http://www.efsa.europa.eu/en/efsajournal/doc/2760.pdf
European Food Safety Authority re-evaluation of food additives
49. All currently permitted food additives are subject to a re-evaluation by EFSA in
accordance with Regulation (EU) No. 257/2010 that sets out a programme for their
re-evaluation in order of priority. http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:080:0019:0027:EN:PDF
50. Additives are being evaluated by functional groups and priority. The re-evaluation
started with colours, which generally have the oldest evaluations and ending with
sweeteners, which have the most recent. However, if new scientific evidence
emerges, that indicates a possible risk for health or casts doubt on the safety of an
additive; this will trigger an immediate re-evaluation of the relevant additive. Food
business operators producing or using food additives are obliged under Article 26 of
Regulation 1333/2008 to inform the Commission of any new scientific or technical
information that might affect the assessment of the safety of the food additive.
Appendix 1
Differences between Annex II and EC Commission Directives
95/2/EC, 94/35/EC and 94/36/EC
51. The provisions in Annex II reflect, in the main, those in the Annexes of EC Directives
95/2/EC, 94/35/EC and 94/36/EC. However, some unintended inconsistencies have
been noted, and the Commission will be issuing a number of amending Regulations
that will correct these and permit current authorisations to continue where appropriate
after 1 June 2013.
52. Nevertheless, a number of currently permitted food additives uses have been
restricted since 1 June 2013. These include the restrictions on Quinoline Yellow,
Sunset Yellow and Ponceau 4R mentioned above following re-evaluation by EFSA in
September 2009. The use of the food colour lycopene has also been restricted
following an EFSA opinion in January 2008. In addition, as a result of information
from stakeholders that a number of colours in Annex V Part 2 of EC Directive
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94/36/EC are no longer being used, the colours permitted in the following food
categories have been reduced: flavoured processed cheese, preserves of red fruit,
fish paste and crustacean paste, precooked crustacean and smoked fish.
53. Following its suspension in 2007, Red 2G (E 128) is no longer listed as a permitted
colour, nor are Brown FK (E 154) and Ethyl ester of beta-apo-8-carotenic acid (E
160f) as industry indicated that these colours are no longer used.
54. The restrictions on the use and levels for aluminium-containing food additives
referred to in paragraph 43 and set out in Regulation (EU) No. 380/2012 have
resulted in significant changes to the permitted use of aluminium lake versions of
colours (i.e. the process whereby water-soluble food colours are precipitated with an
aluminium salt to form water-soluble pigments called lakes). At present aluminium
lake versions of all colours are permitted but with effect from 1 August 2014 these will
be restricted to certain specified colours set out in Table 3 to Annex II of Regulation
1333/2008. In addition, where aluminium lake colours are used in food there will be a
limit to the aluminium permitted to be present in the food as a result of the aluminium
lake.
55. Annex II is structured by food category, and only the additives listed against a specific
food can be used, in accordance with the relevant provisions. There is no scope for
additives to be permitted by default, as was the case in EC Directives 95/2/EC and
94/36/EC, which permitted certain additives/colours to be used in most processed
foods at quantum satis level. Whilst category 18 in Annex II permits processed foods
not covered by categories 1 – 17 (excluding foods for infants and young children) to
contain Group 1 additives, the colours in Annex V Part 1 of EC Directive 94/36/EC,
previously allowed in most processed foods, are only permitted to be used in the food
categories specified.
56. Certain food additives have been restricted as a result of interpretations agreed
within the EU. In particular, flour, originally considered a processed food in the UK, is
now deemed to be an unprocessed food following agreement of EU Member States
at the Commission’s Working Group on Food Additives, with only a small number of
Group 1 additives permitted. However, self-raising flour is considered to be a bakery
pre-mix, consisting of flour and raising agents. As the pre-mix is to be used in the
preparation of for instance sponge cakes, Group 1 additives (including sodium
bicarbonate) are permitted to be present in the pre-mix by way of the “reverse carryover” provision in Regulation 1333/2008.
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Meat preparations
57.
The scope of the “meat preparations” category (08.2) has been the subject of
extensive discussion in EU food additives working group. UK products such as
breakfast sausages and burger meat with a minimum vegetable and/or cereal content
of 4% are amongst those considered to be meat preparations as defined by
Regulation (EC) No. 853/2004, in which are permitted only a restricted number of
additives; a much wider range of additives is permitted in the meat products category
(08.3).
58. A number of additives that are not in conformity with the provisions of the old
Directives nor with Annex II have been used in meat preparations in several Member
States due to historical differences in interpretation of the legislation. There has
therefore been a need to amend the legislation to permit certain current practices
where appropriate. These amendments are set out in European Commission
Regulation (EC) 601/2014, amending Annex II of Regulation 1333/2008, which came
into force on 25 June 2014 (please see link below).
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0601&from=EN
59. The new legislation will permit a number of additional additives in specific meat
preparations, including phosphates in burger meat with a minimum vegetable and/or
cereal content of 4%; will clarify the definitions of the various meat categories within
the legislation; and will amend the carry-over rule to permit additives to be used in
food ingredients used in unprocessed meat preparations e.g. MSG (E 621) in the
seasonings used in burgers.
60. In compound foods such as Cordon Bleu chicken, in which a fresh meat preparation
is coated with cheese and breadcrumbs, the whole product should be considered a
food consisting of several components i.e. a meat preparation which is not permitted
to be coloured, cheese which can contain certain colours and a breadcrumb coating
which can also contain colours. The note in EC Directive 94/36 which had clarified
this principle will be re-instated in guidance on carry-over which the Commission
intends to draw up within the next few months.
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61. European Commission Guidance on Regulation (EC) No. 853/2004 includes
guidance on the definitions of “meat preparations” and “meat products” (at Section
5.9) which can be used to determine which additives are permitted in individual
products; please see link below:
http://ec.europa.eu/food/food/biosafety/hygienelegislation/docs/guidance_doc_8532004_en.pdf
Food category descriptors
62. In order to ensure uniform interpretation of the food categories in Annex II of
Regulation 1333/2008 the Commission has published descriptors. These should be
used for informal interpretation of the legislation only. Stakeholders can access the
finalised document on the Commission’s website at:
http://ec.europa.eu/food/food/fAEF/additives/docs/guidance_1333-2008_descriptors_annex2_20131218_en.pdf
63. Responsibility for enforcement and interpretation of the law within the UK rests with
local enforcement authorities and ultimately the law courts. Within the EU, Article 19
of Regulation 1333/2008 provides for decisions over specific interpretation issues (for
example over unresolved queries over the interpretation of food categories) to be
made by the Standing Committee on the Food Chain and Animal Health.
Appendix 2
Transitional provisions
Annex II of Regulation 1333/2008
64. In the main Annex II did not apply until 1 June 2013. Until 31 May 2013, the
provisions in Article 2 (1), (2) and (4) of EC Directive 94/35/EC, Article 2 (1) to (6) and
(8) to(10) of EC Directive 94/36/EC and Article 2 and 4 of EC Directive 95/2/EC,
together with the Annexes of all three remained in force. This was to enable
manufacturers to adapt to the new provisions, some of which are more restrictive
than those in the legislation being phased out.
Annex III of Regulation 1333/2008
65. The provisions in Parts 1 (carriers in additives) and 4 (additives in flavourings) and
Section B of Part 5 (additives in nutrients to be used in foods for infants and young
Food additives – Regulation 1333/2008
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children) of Annex III largely reflect those in EC Directive 95/2/EC. Preparations not
complying with the requirements of Parts 1 or 4 or with Section B of Part 5 were
permitted to continue to be marketed in accordance with the provisions of EC
Directive 95/2/EC until 31 May 2013.
66. The provisions in Parts 2 (additives in additives) and 3 (additives used in enzymes)
and Section A of Part 5 (additives used in nutrients) have only recently been
harmonised within the EU. Prior to this, national rules applied. In the UK there was
no specific legislation in these areas, though the addition of any substance to food is
subject to the provisions of Regulation (EC) No. 178/2002 (General Food Law).
Preparations not complying with the requirements of Parts 2 or 3 or with Section A of
Part 5 may continue to be marketed in accordance with national provisions where
they exist until 2 December 2013.
Commission Regulation (EU) No. 380/2012
67. Foods containing aluminium lake colours, which comply with the provisions of EC
Directive 94/36/EC, will be able to continue to be marketed until 1 August 2014.
Appendix 3
Nitrites and nitrates in meat products
68. Authorised levels for nitrites and nitrates in meat and other food products take
account of the opinion of the European Food Safety Authority (EFSA), published on
26 November 2003, which aims to keep levels of nitrosamines as low as possible
whilst maintaining the microbiological safety of food products. In addition, in line with
EFSA’s recommendations, controls on the level of nitrites and nitrates in meat
products, are usually based on added rather than residual amounts. However, a
degree of compromise has been introduced in the legislation in order to allow the
continued production of certain traditional products. These compromises include
provisions which permit traditional UK meat products such as Wiltshire cured ham,
bacon and similar products to be produced based on residual amounts.
69. Other than certain traditional products, the legislation limits the use of potassium and
sodium nitrite in meat products to a maximum amount added of 150 mg/kg, and in
sterilised meat products (F0 > 3), to 100 mg/kg. The use of potassium and sodium
nitrate is permitted only in non-heat-treated meat products, to a maximum amount
added of 150 mg/kg, although nitrates may be present in some heat treated meat
Food additives – Regulation 1333/2008
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products resulting from natural conversion of nitrites to nitrates in a low-acid
environment. The limits for both nitrites and nitrates relate to the maximum amount
that may be added during the manufacture of the product i.e. ingoing limits.
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Traditional meat products
70. The traditional meat products for which derogations have been agreed include
categories for six traditional UK meat products. These are listed in italics, which
indicate they are Member States’ national products. In Annex II of Regulation
1333/2008 they are grouped in food category 0.8.2.4 under three sub-headings:
• traditional immersion cured meat products, including Wiltshire bacon and Wiltshire
ham and similar products and cured tongue (category 08.2.4.1);
• traditional dry cured meat products, including dry cured bacon and dry cured ham
and similar products (category 08.2.4.2); and
• other traditionally cured meat products, which includes jellied veal and brisket
(category 08.2.4.3)
71. For traditional products, the limits for both nitrites and nitrates relate to the maximum
residual levels permitted in finished products. The manufacturing method for each of
these traditional products is described in the legislation.
72. When interpreting the legislation, the information for each specific product should be
read in conjunction with the general description for the type of product. For example,
to meet the specification for Wiltshire bacon, the product would need to comply with:
the description for traditional immersion cured meat products set out at 08.2.4.1 (i.e.
it would need to be immersed in a curing solution containing nitrites and/or nitrates,
salt and other components); AND the manufacturing process for Wiltshire bacon
described in the relevant row under category 08.2.4.1; (i.e. it would need to be
injected with curing solution followed by immersion curing for 3 to 10 days with an
immersion brine solution including microbiological starter cultures).
Traditional products which do not fit into any named category
73. Only certain types of traditional products are specifically referred to in the legislation.
If a product does not meet the requirements for any named product (allowing for
“similar products” explained below), it then defaults to a general category e.g. “meat
product” or “non-heat-treated meat product” and the maximum ingoing permitted
levels should be used.
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“Similar products”
74. The legislation contains the words “and similar products” against many, but not all, of
the categories for which derogations have been granted. The legislation does not
define similar products and currently there are no decisions by the EU Standing
Committee or by a Court. The overall intention of the legislation is to reduce the use
of nitrites and nitrates. During the negotiation of the legislation, which introduced
these restrictions, the Council and European Parliament saw the derogations for
certain traditional products as being of a limited nature, and the Parliament in
particular wished to see specifications, which limit the named derogations. With this
background, we consider that a similar product will closely resemble the product
named (but may obviously have a different name); In addition, it must have been
traditionally produced and produced using the same stages as described in the
manufacturing process though there may be some variation in the times and
temperatures cited.
75. To be 'traditionally produced' we consider a product needs to have been produced for
more than 25 years at the time EC Directive 2006/52 came into force (i.e. since
before September 1981). Traditional is not defined within EU food additives
legislation and it is ultimately for a Court to decide the interpretation. We have
suggested it should be taken to be of the order of 1 generation / 25 years, which
would be in line with Regulation (EC) No 509/2006 of 20 March 2006 on Agricultural
Products and Foodstuffs as Traditional Specialities Guaranteed, that introduced a
legal definition of the term ”traditional”, specifically for the purpose of the regulation.
This definition requires a period of 25 years for production/recipe for a traditional food
that is registered under the Scheme.
Dry cured ham
76. The ‘dry cured ham’ produced in the UK, which is different to that produced
elsewhere in the EU, is defined by way of the manufacturing process specified
against the product listed within category 08.2.4.2. The process used must comply
with that stipulated; otherwise, the product will default into the relevant general meat
product category.
Wiltshire bacon/ham
77. Whilst no definition of Wiltshire cure has been included in the legislation, the
manufacturing process for Wiltshire cured ham and bacon is defined by way of the
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manufacturing process specified against the product listed within category 08.2.4.1.
The use of ‘live’ immersion brines is the main distinguishing factor between Wiltshire
and other cures. The criteria within the manufacturing process state that the
immersion brine solution includes microbiological starter cultures. We do not consider
it is necessary for a culture to be added prior to each immersion; the culture may well
be present, as it traditionally was, from previous use of the immersion solution. The
microorganisms present perform the function of reducing added nitrate to nitrite,
which then goes on to become the active curing compound.
Cure-in-the-bag products
78. Cure-in-the-bag products are injected with curing solution, and not immersed, and it
is possible to accurately regulate the ingoing amount of curing solution. This type of
product therefore falls under the general meat products category (08.2.1 or 08.2.2)
and not in the derogations for traditional immersion cured meat products.
Non-heat-treated meat products
79. Sodium and potassium nitrates are permitted to be added to non-heat treated
products. The European Commission considers that the use of nitrate is not
necessary in products which have been heat treated to the extent that any bacteria
have been destroyed. It follows therefore that the relevance of any heat treatment
and the use of nitrates needs to take into account the stage in which the heat
treatment is applied and the effectiveness of any heat treatment (temperature and
time). For example, a piece of bacon or ham is cooked before consumption (and
possibly before purchase); however, this level of heat treatment could not be
considered to negate the need for nitrates at the earlier stages of preparation.
80. Cooked bacon and ham should therefore be classified as “non heat-treated
products”. In the case of bacon, this would apply to both heat set bacon (briefly
cooked at circa 50 °c in order to partially heat-set some of the protein in order to aid
slicing) and to cured bacon that is cooked prior to addition to a sandwich.
81. Permitted levels of nitrates will depend on whether the product in question falls into
the general (non-heat treated) meat product category (08.2.1) (permitted up to 150
mg/kg) or into one of the traditional categories (08.2.4.1) e.g. Wiltshire bacon/ham
(permitted up to 250 mg/kg) or cured tongue (permitted up to 10 mg/kg).
82. Products that should be considered as “heat treated” and fall within category 08.2.2
include many products, which are cooked after canning.
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‘Bacon, filet de bacon’
83. The entry for ‘Bacon, Filet de bacon’ in category 08.2.4.1 refers to a traditional
French product and is not the same as standard bacon. Hence, the maximum
permitted level (250 mg/kg residual, without added E249 or E250) only applies to this
and similar products.
Conversion factor for potassium salts
84. All levels given in the legislation are for the sodium salts. Conversion factors for the
equivalent potassium salts are:
• To convert sodium nitrite to potassium nitrite: multiply by 1.23
• To convert sodium nitrate to potassium nitrate: multiply by 1.19
85. For example, the maximum amount of sodium nitrite, which can be added to
sterilised meat products, is 100 mg/kg, which is equivalent to 123 mg/kg potassium
nitrite. In addition, the maximum amount of sodium nitrate, which can be added to
non-heat treated meat products, is 150 mg/kg, which is equivalent to178 mg/kg
potassium nitrate.
Vegetable extract nitrites
86. The indirect addition of nitrates to foods via nitrate rich extracts of vegetables such as
spinach or celery should be considered an additive use, and not a food use. In such
cases the extract is being added for preservation as it contains a standardised level
of nitrate and consequently such use would not be permitted by Regulation
1333/2008 as these extracts have not been approved as preservatives.
Appendix 4
Maximum usable doses for salt of aspartame-acesulfame
87. The salt of aspartame-acesulfame (E 962) is only permitted for use in food categories
established for both of its constituent components; aspartame (E951) and acesulfame
K (E950).
88. Maximum usable doses for the salt are expressed in Annex II as either aspartame
(E951) and acesulfame K (E950) as indicated in the footnote to the relevant entry.
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The maximum usable doses for both aspartame (E951) and acesulfame K (E950) are
not to be exceeded by use of the salt of aspartame-acesulfame, either alone or in
combination with E950 or E951.
Method of calculating permitted levels of salt of Aspartame–
acesulfame
89. The maximum usable dose for the salt of aspartame-acesulfame in a particular food
can be calculated by firstly multiplying the maximum usable dose (in the food
concerned) expressed as either acesulfame K or aspartame equivalent by the
molecular weight of salt of aspartame-acesulfame. This figure should then be divided
by the molecular weight of either the acesulfame K or aspartame as appropriate to
obtain the final figure. Examples of this calculation are shown below.
Molecular weight of salt of aspartame-acesulfame = 457.46
Molecular weight of acesulfame K = 201.24
Molecular weight of aspartame = 294.31
Examples
Acesulfame K
Category 14.1.4 “Flavoured drinks, energy-reduced or with no added sugar” – where
the maximum usable dose for the salt is expressed as for acesulfame K = 350 mg/l
350 multiplied by 457.46 = 160111
160111 divided by 201.24 = 795.62
The equivalent permitted level of salt of aspartame-acesulfame is 796 mg/l.
Aspartame
Category 15 “Ready to eat savouries and snacks” – where the maximum usable dose
for the salt is expressed as aspartame = 500 mg/kg
500 multiplied by 457.46 = 228730
228730 divided by 294.31 = 777.17
The equivalent permitted level of salt of aspartame-acesulfame is 777 mg/kg
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